港股异动 | 联邦制药(03933)午前涨超5% 注射用头孢曲松钠通过一致性评价 UBT251注射液获批临床

智通财经
12 Mar

智通财经APP获悉,联邦制药(03933)午前涨超5%,截至发稿,涨4.19%,报14.92港元,成交额1.23亿港元。

消息面上,联邦制药公告,公司全资附属公司珠海联邦制药股份有限公司中山分公司申报的注射用头孢曲松钠(规格:1.0g;2.0g)经中国国家药品监督管理局审批,通过仿制药质量和疗效一致性评价。本次获批将进一步有助于公司巩固于抗感染领域的优势地位。

此外,3月4日,联邦制药发布公告,公司全资附属公司联邦生物科技(珠海横琴)有限公司自主研发的1类创新药UBT251注射液获得美国药品监督管理局(FDA)批准,允许开展慢性肾脏病(CKD)适应症的II期临床试验。此前,该适应症已于2025年1月20日获得中国国家药品监督管理局的临床试验批准。

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